Safety Study of Stopping Thromboprophylaxis Based on Ultrasound Results After Total Knee Replacement

9-10 Days Versus Prolonged Thromboprophylaxis in Patients Without Evidence of Ultrasound Proximal Thromboembolism After Total Knee Joint Replacement: a Randomized Controlled Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00362492

Enrollment

850

Registered

2006-08-10

Start date

2004-06-30

Completion date

2007-06-30

Last updated

2010-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty Replacement, Knee, Thromboembolism

Keywords

TKR, Ultrasonography, asymptomatic deep venous thrombosis, extended duration prophylaxis, short duration prophylaxis

Brief summary

The purpose of this study is to determine whether stopping Low Molecular Weight Heparin (LMWH) thromboprophylaxis is safe after total knee joint replacement. The investigators select patients without proximal thromboembolism assessed by bilateral venous ultrasound examination 7-10 days after surgery. the investigators hypothesis is that stopping thromboprophylaxis is equally effective than prolonging thromboprophylaxis in order to prevent post-surgery complications in this population.

Interventions

PROCEDUREBilateral ultrasound examination 7+/- 2 after surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

46 Years to No maximum

Healthy volunteers

Inclusion criteria

* First total knee joint replacement * Signed informed consent Non-inclusion Criteria: * History of venous thromboembolism/major bleeding/Heparin induced thrombopenia * Active cancer * Long-term anticoagulation

Design outcomes

Primary

Measure	Time frame
Thromboembolism occuring between day 7-35 ;	—
Major bleeding occuring between day 7-35 ;	—
LMWH induced thrombopenia	—
All cause mortality	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026